Class 2 Device Recall Mammo Test

• Date Initiated by Firm: January 21, 2009
• Date Posted: June 01, 2009
• Recall Status: Terminated on June 01, 2009
• Recall Number: Z-1318-2009
• Recall Event ID: 51449
• 510(K)Number: K042095
• Product Classification: x-ray guided stereotactic biopsy system - Product Code JAQ
• Product: Mammo Test Model number 10144185, x-ray guided stereotactic biopsy system
• Code Information: Serial numbers 10102, 10103, 10105, and 10106
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355
• For Additional Information Contact: Michael Van Ryn; 610-219-6300
• Manufacturer Reason for Recall: Table may unintentionally lift during procedure
• FDA Determined Cause: Nonconforming Material/Component
• Action: Siemens Medical Solutions issued a Safety Advisory Notice dated 1/22/09 which informs the customers of the potential issues and recommends that they stop using their MammoTest System until the prone table has been repaired. Linear Medical visited the customers to repair the weld joint on the prone table by January 23, 2009.
• Quantity in Commerce: 4 units
• Distribution: USA distribution to IL, NY, SC, and WA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JAQ